A Study to Evaluate the Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL)

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Primary Purpose

Status

Terminated

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

MyVax

About this trial

This is an interventional trial for B-Cell Chronic Lymphocytic Leukemia focused on measuring B-Cll

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria: Have signed a written informed consent B-CLL diagnosis Rai Stage 0, I, or II Previously untreated Be able to watch and wait for approximately 8 months following submission of blood (or tissue) while Id-KLH is being manufactured Exclusion Criteria: Anti-leukemia treatment prior to beginning immunization Anti-leukemia treatment other than Id-KLH during immunizations Prior malignancy (excluding basal cell carcinoma and cervical carcinoma in situ) Pregnant or lactating Patients with known autoimmune disease (including previously treated autoimmune hemolytic anemia or immune thrombocytopenia) Participation in any other clinical trial in which an investigational agent is administered

Sites / Locations

Outcomes

Primary Outcome Measures

The proportion of patients with positive humoral immune responses

Safety and toxicity

Secondary Outcome Measures

Full Information

NCT ID

NCT00302861

First Posted

March 13, 2006

Last Updated

March 14, 2008

Sponsor

Genitope Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00302861

Brief Title

A Study to Evaluate the Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL)

Official Title

Phase 1/2 Study to Evaluate the Feasibility and Tolerability of Treatment of Previously Untreated B-CLL Chronic Lymphocytic Leukemia (B-CLL) Patients With Recombinant Idiotype Conjugated to KLH (Id-KLH) Administered With GM-CSF

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Terminated

Study Start Date

March 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Genitope Corporation

4. Oversight

5. Study Description

Brief Summary

This is a multi-center, open-label, single arm Phase 1/2 study evaluating the feasibility, safety, and tolerability of a series of 16 immunizations of Id-KLH with GM-CSF in patients with previously untreated B-CLL. The length of the controlled portion of the study is two years. The study will be conducted at investigative sites in the United States.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

B-Cell Chronic Lymphocytic Leukemia

Keywords

B-Cll

7. Study Design

Study Phase

Phase 1, Phase 2

Enrollment

86 (false)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

MyVax

Primary Outcome Measure Information:

Title

The proportion of patients with positive humoral immune responses

Title

Safety and toxicity

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

Inclusion Criteria: Have signed a written informed consent B-CLL diagnosis Rai Stage 0, I, or II Previously untreated Be able to watch and wait for approximately 8 months following submission of blood (or tissue) while Id-KLH is being manufactured Exclusion Criteria: Anti-leukemia treatment prior to beginning immunization Anti-leukemia treatment other than Id-KLH during immunizations Prior malignancy (excluding basal cell carcinoma and cervical carcinoma in situ) Pregnant or lactating Patients with known autoimmune disease (including previously treated autoimmune hemolytic anemia or immune thrombocytopenia) Participation in any other clinical trial in which an investigational agent is administered

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Kipps, M.D.

Organizational Affiliation

University of California, San Diego

Official's Role

Principal Investigator

B-Cell Chronic Lymphocytic Leukemia

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial